Many human patients, especially the elderly, require the administration of several oral medications at various times during the day. The number and type of medications vary depending on the medical conditions under treatment. It is not unusual to have four to six tablets and capsules prescribed per dosing time. Often, the number and type of tablets and capsules for dosing varies depending upon the time of day. The need to ensure proper allocation of the medications is critical. The patient, a caregiver or a healthcare provider has to carefully allocate various tablets and capsules and ensure that the patient ingests the entire allocation at the correct time. Misallocation will cause sub par dosing or overdosing that may lead to undesirable results.
The allocation process can be undertaken at each dosing time. Alternatively, the allocations may be undertaken in advance. Often a storage container with several labeled compartments is used. The tablets and capsules required for a particular day and dosing time are placed within a compartment labeled with that day (e.g., Monday, Tuesday, etc.) and with the time of day for the administration (e.g., before breakfast, with breakfast, with lunch, etc.). The patient then takes, or is administered, the contents of the designated compartment at the appropriate dosing time.
The system described above has several disadvantages. First, the accurate allocation of the tablets and capsules is dependant on the skill and focus of the person undertaking the process. An elderly patient may have problems with eyesight and lack of concentration, leading to misallocation of the medications. If the process is undertaken in haste, there is a potential for medications to become mixed up. The process is made further difficult because the physical appearances of many tablets and capsules are similar and in some cases close to identical. Inaccurate allocation of medications may have serious consequences. For example, a patient may inadvertently be overdosed, leading to harmful side effects, or be under-dosed, leading to sub-optimal treatment.
A second disadvantage of manual tablet and capsule allocation by the user or a caregiver is the inconvenience and physical discomfort to the patient of administering multiple tablets and capsules at a dosing time. For example, for elderly patients and those afflicted with diseases such as Alzheimer's or Parkinson's syndrome, the process of swallowing several tablets or capsules at a single dosing time is a tedious and difficult process.
Commercial machines presently available allow for the semi-automatic allocation of tablets and capsules required by a patient for a particular dosing time. However, such machines are usually designed for internal use within hospitals and other well-controlled healthcare environments. The machines often involve expensive capital equipment that must be purchased by the caregiver or the institution caring for a patient. An example of such a machine is the SafetyPak™ system marketed by the Omnicell Corporation for use in hospitals. The machine repackages tablets and capsules into unit-dose packages (such as blister packs) with barcodes. Patient medication bins are stocked with the unit-dose packages. Nurses and other caregivers administer the medications to patients. Stationary and portable readers allow for the tracking and verification of the packaged medications via evaluation of the barcodes. The barcodes help to ensure that the correct prescribed medications are administered to each patient. Such a system has certain disadvantages. The process involves the repackaging of tablets and capsules and the additional costs associated with such operations. When multiple medications are to be administered, the use of this system necessitates the opening of several packages at each dosing time, which may be difficult for elderly patients or other patients with difficulty opening packages. Also, opening multiple medications is time-consuming for a care-giver in a hospital or assisted living facility.
The present invention solves these problems by providing to each patient several medications required for a single dosing time in a few, but preferably one, capsules. For each dosing time, the capsules are provided in a single sealed container or sachet labeled with the patient's name, the encapsulated medications and their dose, the date for administration, the dosing time and a bar code. The bar code provides a link to a database on the encapsulated medications including identity, dose and details of manufacture of the capsules. At the requisite dosing time, the capsules are administered to the patient with an appropriate amount of fluid.
Another problem with administering medications concerns those patients, both human and veterinary, for whom the use of tablets and capsules is not feasible. Some patients are unable to ingest tablets and capsules in a single and smooth swallowing motion, or lack the desire to ingest such dosage forms. Also, some tablets and capsules have an unpleasant taste or an uncomfortable or unpleasant size. Patients who experience such problems include the elderly, particularly those in assisted living facilities, pediatric patients and patients who have encountered severe trauma due to surgery or involvement in accidents. Also, animals often will not, or cannot, swallow tablets or capsules. In such situations, health care providers desire alternative dosage forms, especially liquids or a semi-solid. For many medications, however, liquid formulations are not commercially available. Such formulations then must be made on an ad hoc basis by using a device such as a mortar and pestle to grind a tablet into particles and then dispersing it in a liquid or semi-solid such as applesauce.
A second objective of the present invention is to solve these problems by providing to each patient one or several medications required for a single dosing time in a sealed container ready for reconstitution into a flavored liquid or semisolid product for oral administration. Flavors, sweeteners and viscosity enhancers accompany the medications in the sealed container. The selection of the flavors, sweeteners and viscosity enhancers is based on each individual patient's preference. When necessary, buffering agents may be added for proper pH control and antioxidants added to prevent oxidative decomposition. The container is labeled with the patient's name, the medications and their dose, flavors, sweeteners, viscosity enhancers, buffering agents and antioxidants where applicable, the date for administration and the dosing time, instructions for reconstitution and a bar code. The bar code provides a link to a database on the medications, flavors, sweeteners, and viscosity enhancers and where applicable buffering agents and antioxidants including identity, dose and details of manufacture. At the appropriate dosing time, the requisite amount of liquid is added to the bottle and the contents agitated to produce a liquid or semi-solid formulation. The formulation is then administered to the patient.
A third problem with the administration of medicines and nutritional supplements is the difficulty in providing optimum dosage amounts because only a limited number of tablet or capsule strengths of a particular medicament are available. In many instances, physicians would like to have the option of easily adjusting the dosage of oral medications based on physiological factors, but are constrained to the dosage amounts allowed by combining available tablet or capsule strengths. This is especially true for human patients who are severely ill, have altered metabolic rates or have other high risk factors and those requiring administration of medications with low therapeutic indices such as oncology, cardiac and bronchodilator drug regimens.
In some instances, the availability of tablets and capsules of varying strengths can provide a partial solution to the problem. A combination of such tablets can provide a dose that is close to the desired target value. Another approach is to physically subdivide tablets by cutting or breaking them. The subdivided tablets can be administered alone or combined with whole tablets to provide a dose that is close to the desired value. These approaches have some inherent disadvantages. It is difficult to provide the exact desired dose to the patient without the availability of tablets or capsules with a large number of varying strengths. Often tablets and capsules with such a range of strengths are not available. The subdivision of tablets is both difficult and inaccurate. The subdivision of the contents of capsules involves the removal and allocation of fine powders. The process is difficult and has the potential for resulting in major inaccuracies. Therefore the approaches do not offer physicians and healthcare providers with easy and accurate techniques to provide the exact dose desired for each patient.
Veterinarians would also like to have the option of being able to prescribe a broad range of dosage amounts. Veterinary patients vary widely in body weight. There is a wide variation in the weights of animals maintained as pets such as dogs, cats, guinea pigs and hamsters.
Variations in weights occur among and within the species. Many present commercial products cannot easily accommodate the medication dosages required by such variations.
A third objective of the present invention is to solve these problems by providing a method and system for preparing individualized dosage forms of a single or multiple medications that alone or in integral multiples provide a desired dosage for an individual patient. The individualized dosage forms may be made in an extremely wide variety of strengths. The dosage forms are preferably capsules filled with pellets. The capsules required for a single dosing time are provided in a sealed container or sachet. Alternatively, the doses can be provided in bottles along with flavors, sweeteners and viscosity enhancers for reconstitution into liquid or semi-solid formulations. The selection of the flavors and viscosity enhancers is based on each individual patient's preference. When necessary, buffering agents may be added for proper pH control, antioxidants added to prevent oxidative decomposition, and other excipients added to control dissolution, stability, etc.
Each capsule container or bottle with material for reconstitution is labeled with the patient's name, the medications and their dose, flavors, sweeteners, viscosity enhancers, buffering agents and antioxidants where applicable, the date of administration and dosing time, instructions for administration and a bar code. The bar code provides a link to a database on the medications, flavors and viscosity enhancers and where applicable, buffering agents and antioxidants including identity, dose and details of manufacture. At the requisite dosing time, the capsules are administered with an appropriate amount of fluid. Alternatively for products for reconstitution, the requisite amount of liquid is added to the bottle and the contents agitated to produce a liquid or semi-solid formulation for administration.
For human patients, the first, second and third objectives provide advantages to patients in residential homes, assisted living facilities, hospices and hospitals and to their healthcare providers. The second and third objectives also provide advantages for the veterinarians and healthcare providers who care for animal patients such as pets, equines and zoo animals.
In many instances, human consumers taking vitamins, mineral supplements or nutraceutical products would like to select their individual doses based on advice from healthcare professionals and their own personal preferences. Present commercial products such as multivitamin tablets do not easily make available such choices to patients.
A fourth objective of the invention is to solve this problem by providing combinations of specific doses of vitamins, mineral supplements or nutraceutical products to human consumers based on individual preferences. The vitamins, mineral supplements or nutraceutical products can be provided in capsules. The capsules required for a single dosing time are provided in a sealed container or sachet. Alternatively, the materials can be provided in bottles along with flavors, sweeteners and viscosity enhancers for reconstitution into liquid or semi-solid formulations. The selection of the flavors and viscosity enhancers is based on each individual patient's preference. When necessary, buffering agents may be added for proper pH control and antioxidants to prevent oxidative decomposition. Each capsule container or bottle with material for reconstitution is labeled with the patient's name, the vitamins, mineral supplements, nutraceutical products, flavors, sweeteners, viscosity enhancers or buffering agents where applicable, and their dose, the date and dosing time, instructions for administration and a bar code. The bar code provides a link to a database on the vitamins, mineral supplements or nutraceutical products and the flavors and viscosity enhancers and where applicable, buffering agents and antioxidants including identity, dose and details of manufacture. At the requisite dosing time, the capsules are administered with an appropriate amount of fluid. Alternatively, for products for reconstitution, the requisite amount of liquid is added to the bottle and the contents agitated to produce a liquid or semi-solid formulation for administration.
The invention described herein provides the following advantages over present practices:    1. An easy and convenient solution for providing multiple oral medications, vitamins, mineral supplements or nutraceutical products either in one capsule or in integral multiples of that one capsule or in one container ready for reconstitution into flavored liquid or semi-solid formulations.    2. The number of capsules for administration represents in many cases a reduction in number from the corresponding number of commercial tablets and capsules that would be required if each medicament was administered separately.    3. The doses of each medicament can be readily adjusted for physiological parameters.    4. An easily accessible manufacturing record is maintained of the complete composition of each dosage form.    5. The products for reconstitution into liquid or semi-solid formulations can be supplied with sweeteners, flavors and viscosity enhancing agents based on the preference of the patient.    6. When needed, buffers and antioxidants are included to provide for optimum stability of the liquid or semi-solid products.    7. The invention can be used both for human and veterinary patients.